EP0446713B1 - Système de séparation du sang - Google Patents

Système de séparation du sang Download PDF

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Publication number
EP0446713B1
EP0446713B1 EP91102992A EP91102992A EP0446713B1 EP 0446713 B1 EP0446713 B1 EP 0446713B1 EP 91102992 A EP91102992 A EP 91102992A EP 91102992 A EP91102992 A EP 91102992A EP 0446713 B1 EP0446713 B1 EP 0446713B1
Authority
EP
European Patent Office
Prior art keywords
bag
blood
outlet
tubing
satellite
Prior art date
Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
Expired - Lifetime
Application number
EP91102992A
Other languages
German (de)
English (en)
Other versions
EP0446713A3 (en
EP0446713A2 (fr
Inventor
Raleigh A. Carmen
Willie J. Lewis
Eva Sajan
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
Bayer Corp
Pall Corp
Original Assignee
Miles Inc
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Filing date
Publication date
Application filed by Miles Inc filed Critical Miles Inc
Publication of EP0446713A2 publication Critical patent/EP0446713A2/fr
Publication of EP0446713A3 publication Critical patent/EP0446713A3/en
Application granted granted Critical
Publication of EP0446713B1 publication Critical patent/EP0446713B1/fr
Anticipated expiration legal-status Critical
Expired - Lifetime legal-status Critical Current

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Classifications

    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M1/00Suction or pumping devices for medical purposes; Devices for carrying-off, for treatment of, or for carrying-over, body-liquids; Drainage systems
    • A61M1/02Blood transfusion apparatus
    • A61M1/0209Multiple bag systems for separating or storing blood components

Definitions

  • This disclosure is concerned generally with collection and separation systems for whole blood and specifically with a blood component separation system that can be partially automated.
  • Whole blood is commonly separated into its major components of less dense plasma and more dense red blood cells (RBCs) by first drawing the whole blood into a plastic bag known as a donor or primary bag. The bag's contents are then centrifuged under controlled conditions to result in a lower, more dense portion of packed RBCs and an upper less dense plasma portion, which may be rich in platelets (platelet rich plasma or PRP).
  • RBCs red blood cells
  • the donor bag is typically connected by plastic tubing to one or more satellite bags into which separated blood components (e.g. the PRP) may be expressed by external manipulation for further processing or use.
  • separated blood components e.g. the PRP
  • the classical method of preparing platelet transfusion products from whole blood collections consists of initial centrifugation of whole blood in a plastic blood bag at relatively low centrifugal force to separate most of the PRP from the red cells.
  • the PRP is commonly expressed into an attached satellite blood bag. This is followed by centrifugation of the PRP in the satellite bag at relatively high centrifugal force to form a lower sediment of platelets and an upper platelet poor plasma (PRP).
  • the sedimented platelets are in the form of a pellet or "button" which is resuspended in a small volume (50-60 mL) of donor plasma to give the platelet concentrate.
  • the buffy coat plus either a small volume of plasma or a synthetic medium is then centrifuged at low centrifugal force to separate platelet concentrate (upper layer) from residual red cells and leukocytes.
  • platelet concentrate upper layer
  • the Amsterdam method while apparently giving respectable platelet yields, was cumbersome and labor-intensive.
  • the buffy coat transfer step required the operator to massage the bag to prevent hang-up of the "sticky" buffy coat layer. These manipulations might influence platelet function and release of granulocyte enzymes. There was also no way to control the volume of buffy coat removed.
  • U.S. Patent 3,911,918 to Turner discloses a blood bag having an hour glass shape. That bag has a top portion for plasma, a bottom portion for RBCs and a middle portion for platelets and white blood cells.
  • the hour glass shape is said to help position clamping or sealing devices at the juncture of the separated components after whole blood in the bag is centrifuged. This system has not been used on any significant commercial scale to date.
  • Our system for separation of blood components comprises a main plastic bag having inlet and at least two outlet ports, all of the outlets being at the top of the bag.
  • One outlet port is in closed communication with or capable of being connected to an empty plasma satellite bag adapted to hold plasma.
  • the other outlet port communicates at one end with a tube extending into and within the bag and close to the bag bottom and at the other end is in closed communication with or capable of being connected to a second bag adapted to hold red blood cells.
  • the second satellite bag contains an RBC preservative solution such as AS-3.
  • whole blood is drawn into the main bag via the inlet port and then centrifuged to form an upper, less dense plasma portion, an intermediate buffy coat portion (containing platelets) and a lower, more dense packed red blood cell portion.
  • Pressure is then applied to the bag to express the upper plasma portion through the first outlet into the empty plasma satellite bag via a conventional blood bag connecting tubing.
  • a sensor or photocell adapted to sense a color change as the last of the plasma (or first of the buffy coat) passes through the tubing.
  • the color change at the start or the top of the buffy coat portion can activate the sensor at which time the sensor activates a clamp (or valve) which closes the tubing connected to the first outlet port.
  • the senor When the tubing of the first outlet is thus closed, the sensor simultaneously opens or activates a clamp (valve) in a tubing connecting the main bag with the second satellite bag adapted to hold red blood cells. This allows passage of the RBCs (from the tube extending into the bottom of the bag) to pass into the second satellite bag until a pre-determined volume of buffy coat remains in the main or primary bag. This leaves only buffy coat and platelets in the original bag.
  • the Figure is a plan view of a preferred blood bag separation system of this disclosure.
  • Our system for the separation of blood components and particularly for the preparation of platelet concentrate from buffy coat comprises a bag having sensor activated clamps or valves associated with each of the outlet ports as part of the bag.
  • the outlet port for the RBCs communicates with a tubular extension extending to the bottom of the bag interior.
  • the tube is flexible to minimize breaking or bending during centrifuging. This also helps avoid bag puncture and breaking of the solvent bond where the tube connects to the outlet port.
  • the tube is preferably transparent and extends to within about 1.27 cm (1/2 inch) of the interior bottom of the bag.
  • it is made from conventional blood bag PVC tubing and has a beveled tip to avoid blockage and assure fluid (RBC) flow even if the end of the tube actually touches or presses against the bag bottom.
  • a preferred system is a "triple" blood bag consisting of a primary or donor bag and two satellite bags pre-connected to the primary bag by conventional blood bag tubing.
  • the primary bag is made using conventional techniques but is modified in that the blood collection bag has a RBC outlet tube extending from a top outlet port to the bottom of the bag as shown in Figure 1. All bags and connecting tubings are made from conventional blood bag plastics (e.g. PVC and the like) and are essentially transparent.
  • the triple unit After collection of whole blood into bag 3, the triple unit is centrifuged at relatively high centrifugal force to form upper plasma component 9, intermediate buffy coat component 13, and lower red cell component 11.
  • the bag 3 is then placed in a simple pressure-separator device (blood bag expresser) consisting of a moving spring-loaded expresser plate and a fixed plate.
  • the separation system includes two on-off tubing clamps, 19 and 31, one on tubing 17 and one on tubing 27, activated by a sensor such as a photocell. Plasma passes through tube 17 while the tubing that conveys red cells passes through tube 27.
  • a simple clamp 19 on tubing 17 is open and a simple clamp 31 on tubing 27 is closed.
  • Plasma is expressed into bag 21 by pressure on bag 3 until red cells (in the buffy coat) are first detected in tubing 17 by the photocell sensor 16, at which time clamp 19 on tubing 17 closes in response to an electrical signal on wire line 25 from sensor 16 and the clamp 31 on tubing 27 opens in response to a signal on similar line 25.
  • Red cells are then expressed from the beveled bottom 7a of tube extension 7 through the top of bag 3 into second satellite bag 35 containing a conventional red cell preservation solution such as AS-3 or the like (not shown).
  • the expression continues until only a volume of about 50mL (the buffy coat 13) remains in bag 3. This volume may be set, if desired, by a simple stop between the expresser plate and the backplate against which the bag 3 is pressed in an otherwise conventional blood bag expresser.
  • a preferred method of processing buffy coat to platelet concentrate after centrifugation is as follows. After the plasma and RBC expressions and detaching the plasma bag 21 and the red cell bag 35, the buffy coat 13 is held in the primary bag 3 overnight, preferably at room temperature with agitation. A number of bags containing buffy coat, preferably 6, are pooled together using a Sterile Connection Device (e.g. such as that shown in U.S. Patent 4,507,119) into a bag containing a platelet additive solution. A platelet pooling bag such as that shown in U.S. 4,857,190 to S. Wada and B. Kuhleman can be used.
  • a Sterile Connection Device e.g. such as that shown in U.S. Patent 4,507,119
  • a platelet pooling bag such as that shown in U.S. 4,857,190 to S. Wada and B. Kuhleman can be used.
  • the pool of platelets is centrifuged at low centrifugal force to form an upper platelet concentrate (PC) layer and a lower layer of undesirable red cells and leukocytes.
  • the PC may also be expressed through a leukocyte filter (e.g. as shown in U.S. 4,810,378 to R.A. Carmen et al) into a 1000 mL storage bag made of a plastic with high 02 and CO2 transmission rates for storage (e.g. as shown in U.S. 4,280,497 to Warner et al.).
  • the triple bag system of this invention was used to prepare components including buffy coat platelet concentrate from 6 individual units of blood.
  • the buffy coats were processed individually rather than as a pool.
  • Whole blood was collected into a primary blood bag and the bag was centrifuged at 3000Xg for 9 minutes.
  • the plasma upper layer was expressed into an attached empty satellite bag followed by expression of red cell lower layer from the bottom and out of the top of the primary bag into an attached bag containing AS-3 RBC preservation solution.
  • Platelet counts were performed on all fractions using either an electronic cell counter (plasma and platelet concentrate) or a manual method. Data are summarized in the table below.

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  • Health & Medical Sciences (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Vascular Medicine (AREA)
  • Engineering & Computer Science (AREA)
  • Anesthesiology (AREA)
  • Biomedical Technology (AREA)
  • Hematology (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • External Artificial Organs (AREA)
  • Medicines Containing Material From Animals Or Micro-Organisms (AREA)

Claims (11)

  1. Système de fractionnement du sang entier en ses composants, comprenant une poche à sang (3) présentant au moins deux lumières de sortie (17) et (27) à sa partie supérieure, à savoir une première lumière (27) et une seconde lumière (17), la première lumière (27) communiquant avec un élément tubulaire (7) pénétrant et s'engageant à l'intérieur de la poche (3) et se terminant à une distance juste au-dessus du fond de la poche.
  2. Système suivant la revendication 1, dans lequel l'élément tubulaire s'étend jusqu'à environ 1,27 cm (1/2 in) du fond de l'intérieur de la poche.
  3. Système suivant la revendication 2, dans lequel l'élément tubulaire est flexible et se termine en biseau.
  4. Système suivant la revendication 1, dans lequel la seconde lumière de sortie communique avec une première poche à sang (21) satellite par une tubulure.
  5. Système suivant la revendication 4, dans lequel la tubulure communiquant avec une pince extérieure (19) contient un capteur (16) qui arrête le passage du fluide dans la tubulure.
  6. Système suivant la revendication 1, dans lequel la première lumière de sortie communique avec une seconde poche à sang (35) satellite par une tubulure.
  7. Système suivant la revendication 6, dans lequel la tubulure communiquant avec une pince extérieure (19) comprend un capteur (16) arrêtant le passage du fluide dans la tubulaire.
  8. Système suivant la revendication 5, dans lequel le capteur, après détection et arrêt du passage du fluide dans la tubulure, communique avec et ouvre une vanne extérieure (19) sur la tubulure reliant la seconde lumière de sortie à la poche à sang de manière que du fluide puisse être transféré de la poche à la seconde poche satellite par la lumière de sortie.
  9. Procédé pour fractionner du sang en ses composants, comprenant les étapes qui consistent :
    (a) à introduire du sang entier dans une poche à sang (3) présentant au moins deux lumières de sortie (17) et (27) à la partie supérieure de la poche (3), l'une des lumières de sortie communiquant avec un élément tubulaire (7) débouchant et s'engageant dans la poche et se terminant à environ 1,27 cm (1/2 in) du fond intérieur de la poche ;
    (b) à centrifuger la poche à sang (3) avec une force centrifuge relativement grande pour former une fraction supérieure (9) de plasma, une fraction intermédiaire (13) formée d'une couche leucocytaire et une fraction inférieure formée d'hématies ;
    (c) à exercer une pression sur la poche pour en exprimer le plasma par une lumière de sortie ; et
    (d) à exercer une pression sur la poche pour en exprimer la protéine des globules rouges par l'élément tubulaire.
  10. Procédé suivant la revendication 9, dans lequel chaque lumière de sortie est en communication obturée par l'intermédiaire de la tubulure avec une poche satellite (21, 35).
  11. Procédé suivant la revendication 9, dans lequel les tubulures reliant les poches satellites aux lumières de sortie comprennent un capteur (16) et une pince (19, 31) qui coopèrent d'une manière prédéterminée pour ouvrir et fermer le passage au fluide par les lumières de sortie.
EP91102992A 1990-03-13 1991-02-28 Système de séparation du sang Expired - Lifetime EP0446713B1 (fr)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
US493024 1990-03-13
US07/493,024 US5102407A (en) 1990-03-13 1990-03-13 Blood separation system

Publications (3)

Publication Number Publication Date
EP0446713A2 EP0446713A2 (fr) 1991-09-18
EP0446713A3 EP0446713A3 (en) 1992-01-29
EP0446713B1 true EP0446713B1 (fr) 1994-08-10

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EP91102992A Expired - Lifetime EP0446713B1 (fr) 1990-03-13 1991-02-28 Système de séparation du sang

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US (1) US5102407A (fr)
EP (1) EP0446713B1 (fr)
AT (1) ATE109655T1 (fr)
CA (1) CA2037813A1 (fr)
DE (1) DE69103297T2 (fr)
DK (1) DK0446713T3 (fr)
ES (1) ES2056508T3 (fr)

Cited By (1)

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US5616254A (en) 1990-11-06 1997-04-01 Pall Corporation System and method for processing biological fluid

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Also Published As

Publication number Publication date
US5102407A (en) 1992-04-07
ES2056508T3 (es) 1994-10-01
CA2037813A1 (fr) 1991-09-14
DE69103297D1 (de) 1994-09-15
ATE109655T1 (de) 1994-08-15
DK0446713T3 (da) 1994-09-19
EP0446713A3 (en) 1992-01-29
DE69103297T2 (de) 1994-12-01
EP0446713A2 (fr) 1991-09-18

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